Rectus sheath pain control after major abdomino-pelvic surgery

Completed

• Conditions: Pelvic cancer; Cancer; Malignant neoplasm of pelvis

• Registration Number: ISRCTN77620476
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-26
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Diagnosed with a surgical/medical condition requiring a midline laparotomy and exenterative procedure
2. Willing and able to provide informed consent for participation in the study
3. Male or female aged 18 years or over

Exclusion Criteria

1. Refusal to participate in the trial/provide informed consent
2. Unable to provide informed consent
3. Inappropriate surgical approach, e.g. laparoscopic
4. Contra-indications to an epidural catheter or rectus sheath catheter

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is rectus sheath catheter based analgesia equivalent to epidural based analgesia in patients undergoing major abdomino-pelvic surgery in terms of safety and efficacy? <br>Safety is assessed by recording the number of adverse events and complications associated with the trial. Efficacy is assessed by a number of means: patient pain scores, time to mobilisation, time to flatus, time to bowel opening, and readmission rate. The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period.

Secondary Outcome Measures

Name	Time	Method
1. Procedural time<br>2. Total blood loss/transfusion<br>3. Hypotensive episodes<br>4. Urine output<br>5. Total intravenous fluids administered<br>6. Patient mobilisation<br>7. Opiate avoidane<br>8. Gastro-intestinal morbidity<br>9. Respiratory morbidity<br>10. Demands on nursing/medical care<br>11. Cost-effectiveness<br>12. Patient length of stay<br>13. Patient acceptability<br>The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period